NDC codes

FDA NDC Directory
Product NDC (as listed)69168-437Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0437Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
69168-437-0669168043706120 TABLET, FILM COATED in 1 BOTTLE (69168-437-06)Marketed from Nov 22, 2022
69168-437-9869168043798200 TABLET, FILM COATED in 1 BOTTLE (69168-437-98)Marketed from May 18, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Allergy Relief Non DrowsySuffix: Non Drowsy
Generic name (nonproprietary)
fexofenadine hcl
Active ingredients
Fexofenadine hydrochloride — 60 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Allegiant HealthNDC labeler code 69168
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211075
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 69168-437_87568273-1744-4d82-a57f-8742b30d0122SPL ID 87568273-1744-4d82-a57f-8742b30d0122SPL set ID 219606a8-9a3e-4c30-adb1-984f3f4e72c7RxCUI 997501UNII 2S068B75ZU
Pharmacologic class
Histamine-1 Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469168043706 followed by a unit qualifier and the quantity

Package 69168-0437-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69168-437

What is NDC 69168-437?
69168-437 is the product NDC for Allergy Relief Non Drowsy (fexofenadine hcl), Fexofenadine hydrochloride 60 mg/1 tablet, film coated, listed with the FDA by Allegiant Health. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Allergy Relief Non Drowsy (Fexofenadine HCl).
What is the active ingredient?
Fexofenadine hydrochloride.
Who is the labeler?
Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Allergy Relief Non Drowsy?
2 other product NDCs are listed under this name. See all Allergy Relief Non Drowsy NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Allergy Relief Non Drowsy NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Allergy Relief Non Drowsyfexofenadine hclFexofenadine hydrochloride 180 mg/1CapsuleOralWinCo Foods67091-38667091-0386-15
Allergy Relief non drowsyfexofenadine hclFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralMEIJER, INC.41250-50641250-0506-1541250-0506-3041250-0506-45+1 more

Other NDCs under ANDA 211075

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211075
ProductStrengthForm · routeLabelerProduct NDC
12HR Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralCARDINAL HEALTH70000-0586
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralSafeway, Inc.21130-451
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1TabletOralSafeway, Inc.21130-821
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralTOPCO ASSOCIATES LLC36800-653
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralHEB37808-391
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralHEB37808-392
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralBi-Mart37835-602
allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-292
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralHYVEE INC42507-192
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1TabletOralCVS PHARMACY, INC51316-801
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDISCOUNT DRUG MART53943-392
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1TabletOralFamily Dollar (FAMILY WELLNESS)55319-965
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralAAA PHARMACEUTICAL, INC.57344-292
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralAMERIFOODS TRADING COMPANY61504-192
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCHAIN DRUG MARKETING ASSOCIATION INC63868-334
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1TabletOralBest Choice (Valu Merchandisers Company)63941-801
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralMARC GLASSMAN, INC.68998-292
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1Capsule, CoatedOralAllegiant Health69168-413
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralCVS PHARMACY69842-492
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralHARRIS TEETER72036-191

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